The FDA did NOT grant the 1996 petition. Within the 1996 petition, filed by Public Citizen, they requested the following:

Actions Requested
1. Immediately require a warning in bold type in the official product labeling (package insert) for all fluoroquinolone antibiotics sold in the U.S. (see suggested wording below).

2. Immediately require that a MedGuide (patient package insert) be distributed with all new and refill fluoroquinolone prescriptions warning the public of possible tendon damage and informing the public to stop using the drug and contact their physicians if tendon pain develops (see suggested wording below).

3. Immediately inform all U.S. physicians through a “Dear Doctor Letter” by registered mail about the risk of tendon rupture with fluoroquinolone antibiotics.

4. Immediately inform all other U.S. health professionals through the FDA Medical Bulletin about the new warning.

The specific warning requested by Public Citizen is as follows:

Tendinitis and rupture have been reported both in the U.S. and abroad from the use of fluoroquinolone antibiotics most frequently involving the Achilles tendon. Reports have also been made involving the rotator cuff (the shoulder), the hand, the long tendon of the biceps and the long extensor of the thumb. This appears to be a rare but potentially serious class effect of fluoroquinolone antibiotics.
This reaction appears to be more common in those treated concurrently with corticosteroids; with increasing age; and in renal transplant recipients but cases have occurred in people without any of these risk factors. Onset of symptoms is sudden and has occurred as soon as 24 hours after beginning treatment. Most patients have recovered completely after one to two months. The onset of tendon pain calls for immediate withdrawal of fluoroquinolone antibiotics.

This is the warning that was added instead:

“Ruptures of the shoulder, hand, and Achilles tendons that required surgical repair or resulted in prolonged disability have been reported with [the specific drug name]. [The specific drug name] should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been confidently excluded. Tendon rupture can occur at any time during or after therapy with [the specific drug name].”

This warning was NOT in BOLD TYPE or Black Boxed. It was hidden within the package insert along with the laundry list of other adverse reactions associated with this class. Nothing was done to bring anyone’s attention to this new warning. NO Dear Doctor letters were sent, and other than a brief notice published by the FDA in an obscure FDA journal that is no longer even being published, nothing further was done to inform either the patient or the treating physician.

The latest petition seeking these very same changes was filed in 2005, and NOT 2006 as stated within this article. The Office of Attorney General, State of Illinois’s petition to the FDA was filed May 18, 2005. A full year before the one filed by Public Citizen. As such the FDA did NOTHING for a full three years regarding this issue until Public Citizen SUED them in January of 2008 for failing to respond to these petitions as required by law.

The numbers cited regarding what is to be found with the FDA database is also in error. The latest analysis showed them to be 50% higher than this article states.

Last but not least the FDA did NOT order Ortho-McNeil to put a “black box” warning on Levaquin. But rather pointed out the NEED for such an additional warning for all the fluoroquinolone drugs and REQUESTED that the various manufacturers do so.
Since this was done on July 8, 2008, the various manufacturers had until August 8, 2008 to reply to this request, and if they felt it to be unreasonable or unnecessary, they could disagree with the FDA stating reasons why they felt this to be so. The latest response from the FDA that we received on August 14, 2008 stated the following:

“We have asked the manufactures to box the warning regarding tendon ruptures. The new label has to be reviewed and approved by the FDA and that process has not been completed yet.”

So as one can see the FDA and the various manufacturers are once again dragging their feet concerning this issue. As of August 17, 2008, the FDA has yet to mandated such a warning be added. They simply asked nicely that this be done. The manufacturers may very well refuse to do so.

Nor did the FDA even ask that this Black Box Warning be added immediately. They may very well allow the manufacturers to exhaust their current stock of pre printed labels, which could take years, before the new ones become available. One also has to take into consideration the fact that the drugs currently in the market place would NOT benefit from this change, as they would still be using the old labels. The FDA also REFUSED to mandate the Dear Doctor Letters, which ALL three petitions, (the ones filed in 1996, 2005 and 2006) requested, which would have brought this to the immedate attention of treating physicians. Who to this day, even though this association has been reported since 1982, refuse to associate such injury with this class.

Since this ‘review’ of the tendon issues has been ongoing since 1982, more than two and one half decades now, it may very well take yet another decade before we see such Black Box Warnings within the package inserts.

Mr. David T. Fuller
Director
Fluoroquinolone Toxicity Research Foundation
http://www.fqresearch.org